Meeting News

THEMIS, TWILIGHT, other major trials spotlighted at CMHC

CHICAGO — Healio presents live updates from the late-breaking trials session at the Cardiometabolic Health Congress.

Presenters highlighted notable recent research involving new ways to address cardiometabolic health, including association between metabolic surgery with major adverse CV outcomes, THEMIS and THEMIS-PCI, TWILIGHT, AUGUSTUS and ORION-11 trials.

Metabolic surgery and CV outcomes

Metabolic surgery for patients with obesity and type 2 diabetes was linked to lower incidence of major adverse CV events compared with nonsurgical methods of metabolic management, according to research published in JAMA and discussed here.

Robert H. Eckel

“The primary objective here was to investigate the relationship between metabolic or bariatric surgery and incident major adverse cardiovascular effects,” Robert H. Eckel, MD, professor of medicine, emeritus division of endocrinology, metabolism and diabetes division of cardiology at the University of Colorado Anschutz Medical Campus, said in his presentation. “The authors concluded that among patients with type 2 diabetes and obesity, metabolic surgery compared with nonsurgical management was associated with a significantly lower risk of incident major adverse CV events. The findings from this observational study must be confirmed in randomized controlled trials.”

Healio previously reported on the findings of this study at the European Society of Cardiology Congress. Read more

THEMIS and THEMIS-PCI

THEMIS evaluated ticagrelor (Brilinta, AstraZeneca) added to low-dose aspirin vs. aspirin alone among patients with diabetes and stable CAD, but no history of MI or stroke. THEMIS-PCI, the prespecified subgroup analysis, looked at dual antiplatelet therapy vs. aspirin alone among patients with a history of PCI, according to research presented at the ESC Congress.

Deepak L. Bhatt

“These are patients who could actually tolerate being on dual antiplatelet therapy without bleeding and there were significant reductions in a variety of endpoints including MI and ST elevation in the overall intention-to-treat population,” Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and Cardiology Today Editorial Board Member, said during his presentation. “Ischemic stroke was reduced, acute limb ischemia was reduced and in the on-treatment analysis, all-cause mortality was also significantly reduced.”

Healio previously reported on THEMIS and THEMIS-PCI at the ESC Congress. Read more

TWILIGHT

Among patients who underwent PCI with a drug-eluting stent and were prescribed DAPT for 3 months, subsequent ticagrelor monotherapy lowered bleeding risk without raising ischemic risk compared with continued DAPT, according to findings published in The New England Journal of Medicine.

“The take-home message here is that if the patient is at high bleeding risk, dropping to one antiplatelet for the patient isn’t such a bad idea,” Bhatt said. “But if there is a low bleeding risk and a high ischemic risk, I would probably still go with dual antiplatelet therapy. But again, it’s challenging because this isn’t one size fits all, it’s a bit more nuanced than that.”

Healio previously reported on the results of the TWILIGHT study at TCT. Read more

AUGUSTUS

An antithrombotic regimen that includes a P2Y12 inhibitor and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), without aspirin, resulted in less bleeding and fewer hospitalizations, with no difference in ischemic events compared with other regimens that included a vitamin K antagonist, aspirin or both in patients with atrial fibrillation who had ACS and/or underwent PCI, according to findings published in The New England Journal of Medicine.

“This is something that’s certainly available right now and FDA-approved, unlike THEMIS and THEMIS-PCI that I mentioned, which is going to be submitted,” Bhatt said. “The bottom line is there are a lot of options out there and a lot of new options based on data, based on FDA labeling, which makes life interesting for those of us in clinical practice that are prescribing these agents, but it also makes it very complex.”

Healio previously reported on the findings of the AUGUSTUS trial at the ACC Scientific Session. Read more

ORION-11

Inclisiran, an investigational cholesterol-lowering therapy in the small-interfering RNA class, achieved durable and potential LDL reduction with twice-yearly injections, according to data presented at the European Society of Cardiology Congress.

Inclisiran sodium 300 mg (The Medicines Company) administered twice yearly was well tolerated and safe, with an adverse event profile similar to treatment with placebo.

Christie M. Ballantyne

“There has been a lot of concern with a drug that works in the liver [about] what happens in terms of adverse events in the liver,” Christie M. Ballantyne, MD, professor of medicine at the Baylor College of Medicine, said during his presentation. “The data, in regard to the safety of this agent, looked good in this study and nothing showed up in regard to the liver, kidney or muscle. It met the primary endpoints, and there was a consistent reduction in LDL cholesterol.”

Healio previously reported on the findings from ORION-11 from the European Society of Cardiology Congress. Read more

References:

Skyler JS, et al. FDA Updates and Late Breaking Trials. Presented at: Cardiometabolic Health Congress; Oct. 10-13, 2019; Chicago.

Aminian A, et al. JAMA. 2019;doi:10.1001/jama.2019.14231.

Bhatt DL, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31887-2.

Lopes RD, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1817083.

Mehran R, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1908419.

Ray KK, et al. Late Breaking Science in Prevention 1. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.

Steg PG, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1908077.

Disclosures: Ballantyne reports he received consultant fees from Akcea, Amarin, Amgen, Arrowhead, AstraZeneca, Boehringer Ingelheim, Corvidia, Esperion, Intercept, Janssen, Matinas BioPharma, Merck, Novo Nordisk, Regeneron and Sanofi Synthelabo; and has received grant/research support from Akcea, Amgen, Esperion, Novartis, Regeneron and Sanofi Synthelabo. Bhatt reports he has financial ties with numerous pharmaceutical and device companies, including AstraZeneca, Bristol-Myers Squibb and Pfizer. Eckel reports he has a financial relationship with Sanofi Regeneron, serves on a scientific advisory board for Kowa for the PROMINENT trial and serves on an advisory board for Merck and Novo Nordisk.

CHICAGO — Healio presents live updates from the late-breaking trials session at the Cardiometabolic Health Congress.

Presenters highlighted notable recent research involving new ways to address cardiometabolic health, including association between metabolic surgery with major adverse CV outcomes, THEMIS and THEMIS-PCI, TWILIGHT, AUGUSTUS and ORION-11 trials.

Metabolic surgery and CV outcomes

Metabolic surgery for patients with obesity and type 2 diabetes was linked to lower incidence of major adverse CV events compared with nonsurgical methods of metabolic management, according to research published in JAMA and discussed here.

Robert H. Eckel

“The primary objective here was to investigate the relationship between metabolic or bariatric surgery and incident major adverse cardiovascular effects,” Robert H. Eckel, MD, professor of medicine, emeritus division of endocrinology, metabolism and diabetes division of cardiology at the University of Colorado Anschutz Medical Campus, said in his presentation. “The authors concluded that among patients with type 2 diabetes and obesity, metabolic surgery compared with nonsurgical management was associated with a significantly lower risk of incident major adverse CV events. The findings from this observational study must be confirmed in randomized controlled trials.”

Healio previously reported on the findings of this study at the European Society of Cardiology Congress. Read more

THEMIS and THEMIS-PCI

THEMIS evaluated ticagrelor (Brilinta, AstraZeneca) added to low-dose aspirin vs. aspirin alone among patients with diabetes and stable CAD, but no history of MI or stroke. THEMIS-PCI, the prespecified subgroup analysis, looked at dual antiplatelet therapy vs. aspirin alone among patients with a history of PCI, according to research presented at the ESC Congress.

Deepak L. Bhatt

“These are patients who could actually tolerate being on dual antiplatelet therapy without bleeding and there were significant reductions in a variety of endpoints including MI and ST elevation in the overall intention-to-treat population,” Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and Cardiology Today Editorial Board Member, said during his presentation. “Ischemic stroke was reduced, acute limb ischemia was reduced and in the on-treatment analysis, all-cause mortality was also significantly reduced.”

Healio previously reported on THEMIS and THEMIS-PCI at the ESC Congress. Read more

TWILIGHT

Among patients who underwent PCI with a drug-eluting stent and were prescribed DAPT for 3 months, subsequent ticagrelor monotherapy lowered bleeding risk without raising ischemic risk compared with continued DAPT, according to findings published in The New England Journal of Medicine.

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“The take-home message here is that if the patient is at high bleeding risk, dropping to one antiplatelet for the patient isn’t such a bad idea,” Bhatt said. “But if there is a low bleeding risk and a high ischemic risk, I would probably still go with dual antiplatelet therapy. But again, it’s challenging because this isn’t one size fits all, it’s a bit more nuanced than that.”

Healio previously reported on the results of the TWILIGHT study at TCT. Read more

AUGUSTUS

An antithrombotic regimen that includes a P2Y12 inhibitor and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), without aspirin, resulted in less bleeding and fewer hospitalizations, with no difference in ischemic events compared with other regimens that included a vitamin K antagonist, aspirin or both in patients with atrial fibrillation who had ACS and/or underwent PCI, according to findings published in The New England Journal of Medicine.

“This is something that’s certainly available right now and FDA-approved, unlike THEMIS and THEMIS-PCI that I mentioned, which is going to be submitted,” Bhatt said. “The bottom line is there are a lot of options out there and a lot of new options based on data, based on FDA labeling, which makes life interesting for those of us in clinical practice that are prescribing these agents, but it also makes it very complex.”

Healio previously reported on the findings of the AUGUSTUS trial at the ACC Scientific Session. Read more

ORION-11

Inclisiran, an investigational cholesterol-lowering therapy in the small-interfering RNA class, achieved durable and potential LDL reduction with twice-yearly injections, according to data presented at the European Society of Cardiology Congress.

Inclisiran sodium 300 mg (The Medicines Company) administered twice yearly was well tolerated and safe, with an adverse event profile similar to treatment with placebo.

Christie M. Ballantyne

“There has been a lot of concern with a drug that works in the liver [about] what happens in terms of adverse events in the liver,” Christie M. Ballantyne, MD, professor of medicine at the Baylor College of Medicine, said during his presentation. “The data, in regard to the safety of this agent, looked good in this study and nothing showed up in regard to the liver, kidney or muscle. It met the primary endpoints, and there was a consistent reduction in LDL cholesterol.”

Healio previously reported on the findings from ORION-11 from the European Society of Cardiology Congress. Read more

References:

Skyler JS, et al. FDA Updates and Late Breaking Trials. Presented at: Cardiometabolic Health Congress; Oct. 10-13, 2019; Chicago.

Aminian A, et al. JAMA. 2019;doi:10.1001/jama.2019.14231.

Bhatt DL, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31887-2.

Lopes RD, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1817083.

Mehran R, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1908419.

Ray KK, et al. Late Breaking Science in Prevention 1. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.

Steg PG, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1908077.

Disclosures: Ballantyne reports he received consultant fees from Akcea, Amarin, Amgen, Arrowhead, AstraZeneca, Boehringer Ingelheim, Corvidia, Esperion, Intercept, Janssen, Matinas BioPharma, Merck, Novo Nordisk, Regeneron and Sanofi Synthelabo; and has received grant/research support from Akcea, Amgen, Esperion, Novartis, Regeneron and Sanofi Synthelabo. Bhatt reports he has financial ties with numerous pharmaceutical and device companies, including AstraZeneca, Bristol-Myers Squibb and Pfizer. Eckel reports he has a financial relationship with Sanofi Regeneron, serves on a scientific advisory board for Kowa for the PROMINENT trial and serves on an advisory board for Merck and Novo Nordisk.

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